In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical patent owners will welcome this decision as reinforcing the validity of patents during their PTE term, and may consider how it might apply to similar circumstances raised by a patent term adjustment (PTA) award.
Recently the USPTO Patent Trial and Appeal Board (PTAB) revised several of its Standard Operating Procedures (SOPs), including PTAB SOP 1 which relates to how Administrative Patent Judges (APJs) are assigned to cases. SOP 1 also explains why a panel might change, and the limited use of expanded panels.
In an opinion issued November 19, 2018, Judge Chesler of the U.S. District Court for the District of New Jersey found two Orange Book-listed patents for VIMOVO® invalid for indefiniteness in the way certain pharmacokinetic (PK) properties were recited. The opinion supports the court’s summary judgement of invalidity of the patents.
In Yeda Research & Development Co., v. Mylan Pharmaceuticals Inc., the Federal Circuit affirmed the decisions of the USPTO Patent Trial and Appeal Board (PTAB) finding three Copaxone patents invalid as obvious in parallel Inter Partes review (IPR) proceedings. The companion decision pertaining to related district court litigation caught my attention for its use of originally confidential statements to FDA as evidence of the state of the art that supported obviousness. This decision caught my attention for its use of a study published three weeks after the priority date as evidence of the motivation and reasonable-expectation-of-success elements of obviousness.
The USPTO has devised a plan to address the IDS PTA deduction error that incorrectly charges a Patent Term Adjustment (PTA) deduction for Information Disclosure Statements (IDSs) filed with a “safe harbor” statement. Although the USPTO won’t be able to correct the underlying problem until it rolls out its “next generation” information technology systems, it has devised a plan to make it easier for applicants to flag safe harbor IDSs, and easier–and cheaper–to request recalculation of a PTA award when this is the only error.